BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F&P EVAQUA 2

    MDR report key: 24381537 · Received February 18, 2026

    Report

    Report Number
    9611451-2026-00554
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 1, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. SECTION H11: FISHER & PAYKEL (F&P) HEALTHCARE IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D1: BRAND NAME UPDATED. SECTION G4: THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. SECTION H11: METHOD: THE SUBJECT MR290V AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS UNABLE TO BE RETURNED TO F&P HEALTHCARE FOR EVALUATION AS IT HAD BEEN DISCARDED BY THE HEALTHCARE FACILITY. OUR INVESTIGATION IS BASED ON THE INFORMATION AND PHOTOGRAPHS PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: REVIEW OF THE PROVIDED PHOTOGRAPHS CONFIRMED THAT THE MR290V AUTOFEED HUMIDIFICATION CHAMBER HAD A VERTICAL CRACK IN THE CHAMBER DOME. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND WITHOUT THE RETURN OF THE SUBJECT DEVICE, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED FAULT. EVERY MR290V AUTOFEED HUMIDIFICATION CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS AND ANY HOLES, CRACKS, OR LEAKS WOULD BE IDENTIFIED DURING THIS PROCESS. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS THESE TESTS IS REJECTED. THE SUBJECT MR290V AUTOFEED HUMIDIFICATION CHAMBER AND BREATHING CIRCUIT KIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS FOR THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT STATE THE FOLLOWING: - VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED. - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SETS TO PATIENT. - DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED. - APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT, WAS FOUND CRACKED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN MR290V AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED AS A PART OF AN RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT, WAS FOUND CRACKED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365536 F&P EVAQUA 2 BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT268 2103456283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown